Sr. Associate II, Regulatory Affairs Strategy Alcon IncSr. Associate II, Regulatory Affairs StrategyIrvine, CAIn this role, you will develop strong scientific and technical product knowledge and serve as a key resource to country Regulatory Affairs associates by providing regulatory guidance and information. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
Regulatory Affairs & Compliance Analyst, Policies & Procedures CalOptimaRegulatory Affairs & Compliance Analyst, Policies & ProceduresOrange, CA$68,015–$108,824 / yearWe are hoping you will join us as a Regulatory Affairs & Compliance Analyst, Policies & Procedures and help shape the future of healthcare where you'll be an integral part of our OOC - Policies & Procedures team, helping to strive for excellence while we serve our member health with dignity, respecting the value and needs of each of our members through collaboration with our providers, community partners and local stakeholders. Bachelor's degree in health services administration, public health, public policy or related field PLUS 3 years of experience in the health care industry in a public or regulatory affairs role, including experience in policies and procedures development, required; an equivalent combination of education and experience sufficient to successfully perform the essential duties of the position such as those listed above may also be qualifying.
Regulatory Affairs Specialist II Envista Holdings CorpRegulatory Affairs Specialist IIBrea, CA$85,800–$104,800 / yearThis individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Manager II, Regulatory Affairs Tarsus Pharmaceuticals IncManager II, Regulatory AffairsIrvine, CARemote$120,000–$168,000 / yearLet's talk about some of the key responsibilities of the role: Assist in performing and managing the initial part of the workflow (Initial QC, routing, scheduling meetings, etc.) in the Veeva system for material review and approval of the materials submitted from the assigned business units. A Few Other Details Worth Mentioning: The position can be either Remote or based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals.
Associate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion) Arrowhead PharmaceuticalsAssociate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)Los Angeles, CA$180,000–$200,000 / yearProvide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across multiple channels, including digital, social media, websites, emails, print, speaker programs, video testimonials, scientific congresses, and field communications, among others. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Utility Regulatory Affairs Senior Advisor Edison InternationalUtility Regulatory Affairs Senior AdvisorRosemead, CAIn this job, you'll be developing and advocating the Company's positions associated with wholesale generation and energy storage interconnections to SCE's distribution system, including managing the development of revisions to SCE's wholesale distribution access tariff. Become a Utility Regulatory Affairs Senior Advisor at Southern California Edison (SCE) and help meet our goals of interconnecting clean energy resources to SCE's grid.
Manager II, Regulatory Affairs Tarsus PharmaceuticalsManager II, Regulatory AffairsIrvine, CaliforniaRemoteAssist in performing and managing the initial part of the workflow (Initial QC, routing, scheduling meetings, etc.) in the Veeva system for material review and approval of the materials submitted from the assigned business units. Serve as the Regulatory point of contact for the regulatory promotional perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings, as needed.
Executive Director, Regulatory Affairs Arrowhead PharmaceuticalsExecutive Director, Regulatory AffairsLos Angeles, CA$280,000–$320,000 / yearArrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.
Associate Director, Regulatory Affairs Global Regulatory Advertising and Promotion Arrowhead Pharmaceuticals IncAssociate Director, Regulatory Affairs Global Regulatory Advertising and PromotionPasadena, CA$180,000–$200,000 / yearProvide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across multiple channels, including digital, social media, websites, emails, print, speaker programs, video testimonials, scientific congresses, and field communications, among others. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Regulatory Affairs Coordinator University of California, IrvineRegulatory Affairs CoordinatorOrange, CaliforniaFull timeProven organizational skills and attention to detail; ability to multi-task, prioritize a complex and dynamic workload, meet rigid deadlines despite interruptions, frequent workload changes and competing demands, and achieve high productivity/quality within short time frames; skill in working independently, taking initiative and following through on assignments and ability to work as part of a team. *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
Regulatory Affairs Specialist Envista DentistryRegulatory Affairs SpecialistBrea, CaliforniaThis individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Executive Director, Regulatory Affairs Arrowhead Pharmaceuticals IncExecutive Director, Regulatory AffairsPasadena, CA$280,000–$320,000 / yearArrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.
Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs Dendreon CorporationVice President, Medical Affairs, Clinical Operations & Regulatory AffairsSeal Beach, CaliforniaThis executive role ensures alignment across scientific communications, product lifecycle management, clinical development, and regulatory strategy to support the successful development, approval, and commercialization of the company's products and contract manufacturing services (CMS) pipeline. Develop and maintain strategic relationships with physicians, investigators, Key Opinion Leaders (KOLs), healthcare providers, and scientific experts to support clinical development, evidence generation, product adoption, and medical education initiatives.
NewRegulatory Affairs Coordinator 3 Pyramid Consulting, IncRegulatory Affairs Coordinator 3Irvine, CA$50–$55 / hourExecute and support end-to-end distribution-related activities for products across sustaining projects and integration efforts, including certificate lifecycle management, compliance actions such as hard stop holds, distribution control releases for applicable regions (US, EU, ROW), and distribution release closure activities, ensuring alignment with regulatory and operational requirements. Experience with authoring EU technical documentation, supporting notified body change notifications in coordination with cross-functional teams, compiling and supporting 510(k) activities, and product lifecycle maintenance.
Regulatory Affairs Specialist Sakura Finetek USARegulatory Affairs SpecialistTorrance, CaliforniaCollaborates with various internal departments, including Quality, Engineering, R&D, Customer Operations, Sales, and Marketing, as well as external stakeholders such as customers and suppliers, throughout pre-production, production, and post-production phases. Assisting in interactions with regulatory agencies, including submission review and on-site audit support (e.g., FDA inspections for future 510(k)s, IVDR audits related to CE marking design dossiers and technical documentation).
Regulatory Affairs Director VitalConnect IncRegulatory Affairs DirectorCA$150,000–$175,000 / yearWrite, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including device submissions in USA, Europe and other countries. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.
Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA) BeautyHealthSr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)Long Beach, CaliforniaAn employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs. This includes developing regulatory planning, preparing submissions, ensuring ongoing compliance with applicable regulations such as U.S. FDA and international market regulations, and supporting cross-functional teams to bring innovative solutions to market safely and efficiently.
Senior Manager, Regulatory Affairs TMTT Edwards LifesciencesSenior Manager, Regulatory Affairs TMTTIrvine, CA$145,000–$205,000 / yearWorking in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues.
Regulatory Affairs Manager Huisong PharmaceuticalsRegulatory Affairs ManagerSanta Ana, California$38–$48Position Overview Huisong Inc. is seeking an experienced Regulatory Affairs Manager to support regulatory strategy and compliance for dietary supplements, botanical ingredients, herbal extracts, and Traditional Chinese Medicine products. Founded in 1998, Huisong Pharmaceuticals specializes in the research, development, and manufacturing of premium-quality natural ingredients for leading companies in the pharmaceutical, nutraceutical, food and beverage, and personal care industries.
Sr. Regulatory Affairs Specialist - Ad/Promo Prolacta BioscienceSr. Regulatory Affairs Specialist - Ad/PromoDuarte, CA$112,000–$125,000Experience coordinating cross-functional reviews, resolving comments, maintaining trackers, preparing status updates, and supporting timely completion of review, approval, submission, and record-retention activities. Review assigned advertising, promotional, labeling, packaging, digital, scientific, educational, technical, and other external-facing materials for regulatory compliance, intended use, claim support, accuracy, balance, and consistency with approved source documents.
Regulatory Affairs Specialist, Sr. Glidewell DentalRegulatory Affairs Specialist, Sr.Irvine, CaliforniaBehind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
NewRegulatory Affairs Coordinator 3 Pyramid, IncRegulatory Affairs Coordinator 3Irvine, CA$50–$55 / hourFull timeExecute and support end-to-end distribution-related activities for products across sustaining projects and integration efforts, including certificate lifecycle management, compliance actions such as hard stop holds, distribution control releases for applicable regions (US, EU, ROW), and distribution release closure activities, ensuring alignment with regulatory and operational requirements. Experience with authoring EU technical documentation, supporting notified body change notifications in coordination with cross-functional teams, compiling and supporting 510(k) activities, and product lifecycle maintenance.
Director of Regulatory Affairs Radiant Industries IncDirector of Regulatory AffairsEl Segundo, CACraft a modern regulatory strategy based in sound engineering principles with input from executives, our board of directors, and industry experts that brings the safest product to market the fastest. Portable nuclear power with rapid-deploy capability can replace similar-sized diesel generators and provide critical asset support for hospitals, data centers, remote sites, and military bases.
NewBilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA Compliance Macpower Digital Assets Edge Private LimitedBilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA ComplianceLos Angeles, CA$90,000–$140,000 / yearGuided by the core values of Beautiful, Healthy, and Refreshing , they innovate beyond traditional cosmetics and household products, delivering creative solutions tailored to evolving consumer needs. As the Senior Regulatory Affairs Manager , you will ensure regulatory compliance for cosmetic, OTC, dietary supplement, and medical device products in North America—from concept to market launch.
Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA) Beauty Health Group LimitedSr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)Long Beach, CA$107,500–$125,000 / yearAn employee's pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs. This includes developing regulatory planning, preparing submissions, ensuring ongoing compliance with applicable regulations such as U.S. FDA and international market regulations, and supporting cross-functional teams to bring innovative solutions to market safely and efficiently.
Regulatory Affairs Officer Franklin Resources IncRegulatory Affairs OfficerPasadena, CA$128,000–$150,000 / yearWe also offer a comprehensive benefits package, which includes a range of competitive healthcare options, insurance, and disability benefits, employee stock investment program, learning resources, career development programs, reimbursement for certain education expenses, paid time off (vacation / holidays / sick / leave / parental & caregiving leave / bereavement / volunteering / floating holidays) and a motivational wellbeing program. The Regulatory Affairs Officer will help ensure compliance with fast-changing US rules and regulations, including advising on potential strategic impact and coordinating internal groups to implement changes and ensure proper internal controls.
Regulatory Affairs Officer Western Asset Management Company LimitedRegulatory Affairs OfficerPasadena, CA$128,000–$150,000 / yearWe also offer a comprehensive benefits package, which includes a range of competitive healthcare options, insurance, and disability benefits, employee stock investment program, learning resources, career development programs, reimbursement for certain education expenses, paid time off (vacation / holidays / sick / leave / parental & caregiving leave / bereavement / volunteering / floating holidays) and a motivational wellbeing program. The Regulatory Affairs Officer will help ensure compliance with fast-changing US rules and regulations, including advising on potential strategic impact and coordinating internal groups to implement changes and ensure proper internal controls.
Regulatory Affairs and Quality Assurance Specialist SprintRay IncRegulatory Affairs and Quality Assurance SpecialistHuntington Beach, CA$90,000–$120,000 / yearTo All Recruitment Agencies: Without a written agreement signed by an officer of SprintRay: a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly. Whether we're building next-generation AI tools, designing new materials, or supporting our customers on the front lines, we're united by the same passion-transforming digital dentistry and having fun while we do it.
Regulatory Affairs Manager Karwell TechnologiesRegulatory Affairs ManagerIrvine, CAResponsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
Regulatory Affairs Specialist Broadata CommunicationsRegulatory Affairs SpecialistTORRANCE, CAFull timeThis role will support Class I and Class II medical device programs, including technical documentation, design history files, change control, risk management, supplier documentation, labeling review, customer regulatory requests, and audit readiness. Experience with Class II medical devices, 510(k) support, IEC 60601-1, EU MDR technical documentation, or customer-driven regulatory submissions is highly preferred.
Regulatory Affairs Manager Katalyst Healthcares & Life SciencesRegulatory Affairs ManagerIrvine, CAResponsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
Senior Specialist, Regulatory Affairs THV Edwards Lifesciences CorpSenior Specialist, Regulatory Affairs THVIrvine, CA$92,000–$130,000 / yearHow you will make an impact: Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives.
Director, Regulatory Affairs (Labeling) Arrowhead PharmaceuticalsDirector, Regulatory Affairs (Labeling)Los Angeles, CA$210,000–$230,000 / yearManage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Specialist, Regulatory Affairs Surgical Edwards LifesciencesSpecialist, Regulatory Affairs SurgicalIrvine, California$74,000–$104,000 / yearWorking in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.
Regulatory Affairs and Quality Assurance Specialist SprintRayRegulatory Affairs and Quality Assurance SpecialistHuntington Beach, California$90,000–$120,000Without a written agreement signed by an officer of SprintRay: a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly. Whether we’re building next-generation AI tools, designing new materials, or supporting our customers on the front lines, we’re united by the same passion—transforming digital dentistry and having fun while we do it.
Senior Specialist, Regulatory Affairs Surgical Edwards LifesciencesSenior Specialist, Regulatory Affairs SurgicalIrvine, CA$92,000–$130,000 / yearPrepare, compile, and support global regulatory submissions for assigned products, including: U.S. submissions (e.g., 510(k)s, IDEs, PMAs, PMA supplements, annual reports) EU submissions under the Medical Device Regulation (MDR) (e.g., Technical Documentation, Design Dossiers, STEDs, clinical evaluation documentation, and responses to Notified Body questions) Support CE marking activities and interactions with Notified Bodies for Class III implantable devices. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.
Junior Regulatory Affairs Specialist Pro-Dex IncJunior Regulatory Affairs SpecialistIrvine, CA$28.85–$31.25 / hourResponsibilities include support for QA/RA related operational activities within the Quality System that may include processes such as recall investigations/activities, Audits, Deviations and Process/Product Validations and Product Development/Design Control deliverables. Experience in industrial hygiene/safety, government regulations, EU MDR, ISO, MDSAP, operational auditing, work flow analysis, technical writing, and manufacturing operations preferred.
Analyst II, Rates and Regulatory Affairs Liberty Utilities (Canada) Corp.Analyst II, Rates and Regulatory AffairsCA$75,000–$100,000 / yearThe Regulatory Analyst will report to the Director, Rates and Regulatory Affairs, and will undertake complex financial and operational research and analysis for priority regulatory projects or rate issues for Liberty's Central Region Utilities. Our rapid growth has led both our regulated utility services and renewable energy business groups into different geographies and commodities, but our purpose remains unchanged - Sustaining Energy and Water for Life.
Senior Manager, Regulatory Affairs RitualSenior Manager, Regulatory AffairsLos Angeles, CaliforniaRemoteProactively manage team capacity, anticipating bandwidth constraints, redistributing workload, and communicating trade-offs before they become obstacles for cross-functional partners. You'll report directly to the Director of Legal & Strategy, lead the regulatory team, and serve as a critical cross-functional partner to Legal, R&D, Innovation, Marketing, Quality, and Operations.
Director of Licensing & Regulatory Affairs (SMR / MMR Programs) BaRupOn LLCDirector of Licensing & Regulatory Affairs (SMR / MMR Programs)Irvine, CABaRupOn LLC is seeking a highly experienced Director of Licensing & Regulatory Affairs to lead all regulatory strategy, licensing execution, and compliance activities for its Small Modular Reactor (SMR) and Micro Modular Reactor (MMR) programs in the United States. The ideal candidate brings deep, direct NRC engagement experience, a thorough command of U.S. nuclear regulatory frameworks, and the leadership ability to build and manage a high-performing regulatory team in a fast-moving, mission-driven environment.
Manager Regulatory Affairs Device-Combination Products AbbVie IncManager Regulatory Affairs Device-Combination ProductsIrvine, CARepresents Device Regulatory Affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaCA$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Director, Regulatory Affairs Labeling Arrowhead Pharmaceuticals IncDirector, Regulatory Affairs LabelingPasadena, CA$210,000–$230,000 / yearManage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
VP of Quality & Regulatory Affairs Alliance Medical ProductsVP of Quality & Regulatory AffairsIrvine, CaliforniaThe Vice President of Quality Assurance will be responsible for the design, build, and implementation of the strategic framework of the Irvine Quality organization with a focus on driving effective and efficient business results, operational consistency, and cross-functional alignment. Change management –Champion innovation with the design and execution of changes in operating models as the Quality Unit scale up and develop strategies that impact the work of the Quality team.
Principal Regulatory Affairs Specialist Medtronic MiniMed IncPrincipal Regulatory Affairs SpecialistCARemote$121,000–$205,000 / yearIf you are applying to perform work for MiniMed in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account.
Coord 3, Regulatory Affairs Pyramid, IncCoord 3, Regulatory AffairsIrvine, CA$50–$54 / hourFull timeStrict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry) 5-7 years of experience requiredOur client is a leading Medical technology Industry and we are currently interviewing to fill this and other similar contract positions. Coursework, seminars, and/or other formal government and/or trade association training required Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel Good written and verbal communication skills and interpersonal relationship skills Good problem-solving, organizational, analytical and critical thinking skills Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices Solid knowledge and understanding of global regulatory requirements for new products or product changes.
Jr. Regulatory Affairs Specialist- 100% onsite ConsultNetJr. Regulatory Affairs Specialist- 100% onsiteIrvine, CA$30–$31.25 / hourFor over 25 years, we have connected thousands of consultants with meaningful roles through a personal, communication-driven approach, partnering with a diverse client base to build high-performing teams and create lasting impact. Experience in industrial hygiene/safety, government regulations, EU MDR, ISO, MDSAP, operational auditing, work flow analysis, technical writing, and manufacturing operations preferred.
Manager, Product Integrity, Regulatory & Scientific Affairs Noodle & Boo, Inc.Manager, Product Integrity, Regulatory & Scientific AffairsCerritos, CANoodle & Boo is seeking a highly organized, scientifically rigorous, and detail-oriented Manager, Product Integrity, Regulatory & Scientific Affairs to support the day-to-day execution of formula governance, regulatory documentation, product compliance, technical recordkeeping, claims substantiation, COA review, and manufacturing quality consistency across our premium baby, maternity, and family care portfolio. Reporting to the Founder and ultimately the VP Product / Chief Product Officer, this role is cross-functional and operationally important, but remains a manager-level, hands-on role focused on execution, documentation control, quality follow-up, and compliance support.
NewAssistant Regulatory Affairs Coordinator - Hybrid University of California, IrvineAssistant Regulatory Affairs Coordinator - HybridOrange, CaliforniaFull timeResponsibilities related to regulatory coordination activities include managing and preparing submissions of modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA) and other ancillary committees including, but not limited to, Disease-Oriented Teams (DOTs), Protocol Review and Monitoring Committee (PRMC), Data and Safety Monitoring Board (DSMB), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), and Epidemiology Infectious Prevention (EIP). The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
Senior Manager, Regulatory Affairs Natals IncSenior Manager, Regulatory AffairsLos Angeles, CARemote$144,500–$185,000 / yearProactively manage team capacity, anticipating bandwidth constraints, redistributing workload, and communicating trade-offs before they become obstacles for cross-functional partners. You''ll report directly to the Director of Legal & Strategy, lead the regulatory team, and serve as a critical cross-functional partner to Legal, R&D, Innovation, Marketing, Quality, and Operations.